NCT02536287

Comparison of Total Parathyroidectomy With and Without Autotransplantation

Comparison of Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Without Autotransplantation:A Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: The Second Hospital of Anhui Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare short-term and long-term efficacy of total parathyroidectomy with autotransplantation and total parathyroidectomy without autotransplantation for Secondary hyperparathyroidism.

Detailed description

Background:Secondary hyperparathyroidism (SHPT) is a common disorder in patients with chronic kidney disease. It is caused by permanent stimulation of the orthotopic and heterotopic parathyroid tissue due to phosphate retention, hypocalcemia, and vitamin D insufficiency. Despite the initiation of new therapeutic agents, several patients will require parathyroidectomy.There are three options for the surgical treatment of SHPT:subtotal PTX (3.5-gland resection,SPTX), total PTX with autotransplantation(TPTX+AT), and total PTX without autotransplantation(TPTX).SPTX and TPTX+AT both leave a fragment of activated,proliferated parathyroid tissue.Since the pathophysiological condition of chronic renal failure and maintenance dialysis continues, the growth stimulus persists and may cause recurrent sHPT.The SPTX procedure has a lesser likelihood of a non-functioning remnant, but recurrent disease always requires a neck reoperation that carries a high likelihood of recurrent laryngeal nerve palsy.Therefore most surgeons believe that TPTX+AT is a better procedure for patients with SHPT. Because of the potential complication of permanent hypocalcemia and adynamic bone disease,TPTX was not introduced into clinical practice.However,recent retrospective studies demonstrated patients after TPTX did not develop permanent hypoparathyroidism and adynamic bone disease as initially expected.Postoperative hypocalcemia is temporary.TPTX may provide an alternative strategy to the currently performed procedures mainly because of the reported lower recurrence rates.An 8-year follow-up study showed the recurrence rates after TPTX is 7%.Recurrence rates after TPTX+AT is 21.4%,and the site of recurrence is located in approximately 80% at the graft and in 20% in the neck.However, to the present there is no randomized controlled trial to Compare the effects of total parathyroidectomy with autotransplantation and total parathyroidectomy without autotransplantation.The purpose of this study is to evaluate the short-term and long-term efficacy of total parathyroidectomy without autotransplantation comparison to total parathyroidectomy with autotransplantation. Intervention: One hundred patients with SHPT need undergo parathyroidectomy at the Second Hospital of Anhui medical university were selected and divided into total parathyroidectomy without autotransplantation group and total parathyroidectomy with autotransplantation group, each group contains 50 cases. Results: 1. Clinical data include: intact parathyroid hormone,serum calcium,serum phosphorus,calcium-phosphorus product,hemoglobin,operation time,morbidity,mortality,clinical symptoms and signs,recurrence and reoperation,quality of life scores. 2. Statistical method: groups t-test, analysis of variance were used.

Conditions

• Secondary Hyperparathyroidism

Interventions

Type	Name	Description
PROCEDURE	total PTX without autotransplantation	All parathyroid glands were found and removed and sent for histological confirmation,but without autotransplantation.
PROCEDURE	total PTX with autotransplantation	All parathyroid glands were found and removed and sent for histological confirmation,and then a portion of the smallest, preferably nonnodular parathyroid gland was chosen for autotransplantation,sliced into pieces measuring 1\*1 \*1 mm,and placed into the subcutaneous of the forearm.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-12-01
• Completion: 2018-12-01
• First posted: 2015-08-31
• Last updated: 2015-08-31

Locations

1 site across 1 country: China